US20120065553A1 - Medical device - Google Patents
Medical device Download PDFInfo
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- US20120065553A1 US20120065553A1 US13/147,187 US201013147187A US2012065553A1 US 20120065553 A1 US20120065553 A1 US 20120065553A1 US 201013147187 A US201013147187 A US 201013147187A US 2012065553 A1 US2012065553 A1 US 2012065553A1
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- Prior art keywords
- medical device
- probe
- suction
- temperature
- monitoring means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00084—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
- A61B2017/320084—Irrigation sleeves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2217/00—General characteristics of surgical instruments
- A61B2217/002—Auxiliary appliance
- A61B2217/005—Auxiliary appliance with suction drainage system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0272—Electro-active or magneto-active materials
- A61M2205/0294—Piezoelectric materials
Definitions
- This invention relates to a medical device for the safe and efficient removal of urinary tract stones.
- Urinary tract stones are solid concretions formed from minerals present in urine. Small stones can pass from the body in urine without notice, however, larger stones can become lodged in the ureter, kidneys or bladder causing discomfort and/or pain.
- ESWL extracorporeal shock wave lithotripsy
- invasive techniques such as surgery, basket extraction, laser fragmentation, mechanical shock-wave fragmentation or ultrasonic fragmentation. If fragmentation is used, the fragments of the stone may be allowed to pass from the body in the urine alternatively the fragments may be extracted using basket extraction or suction.
- Ultrasonic probes e.g. probes transmitting energy in the range of from 20 kHz to 200 kHz
- Ultrasonic fragmentation commonly uses a piezoelectric motor to generate ultrasound from a high frequency electrical voltage.
- the piezoelectric motor is usually located in a handpiece and the vibrations resulting from the ultrasound are usually transmitted to a probe that is inserted via an endoscope into the body. This allows the tip of the probe to come into direct contact with a urinary stone, such that the vibrations cause the stone to fragment or wear.
- the present invention offers an improved device for the removal of urinary tract stones.
- a medical device comprising a body and a hollow probe, ultrasound generation means and suction monitoring means, wherein, in use, suction is applied through the hollow probe, and wherein the ultrasound generation means is adjusted in response to a suction flow rate detected by the suction monitoring means.
- Suction may be supplied from a vacuum system within the hospital in which the device is being used, or may be supplied by a separate suction pump.
- the ultrasound generation means may be activated in response and if, following activation of the ultrasound generation means, the suction flow rate increases the ultrasound generation means may be deactivated in response.
- the ultrasound generation means may be activated and/or deactivated manually or automatically in response to a signal generated by the suction monitoring means.
- the signal may be an audible and/or visible alarm to enable a user of the device to manually respond to the suction flow rate detected or the signal may be an electronic signal enabling computer control means to automatically respond to the suction flow rate detected.
- both manual and automatic control of the ultrasound generation means in response to a suction flow rate detected by the suction monitoring means may be enabled. Additionally the frequency and strength of the ultrasound may be varied manually or automatically in response to the extent of the reduction or increase in the suction flow rate.
- the suction flow rate can be reduced by a fragment of a urinary tract stone becoming lodged within the hollow probe or by a stone blocking the tip of the hollow probe because it is too large to enter into the probe.
- Activating the ultrasound generation means when a blockage is detected allows the hollow probe to be used to fragment or wear the stones and thereby clear the blockage.
- suction during a blockage ensures that the stone is held in contact with the probe surface and therefore ensures that the ultrasound vibrations are transmitted efficiently to the stone or stone fragment, resulting in the efficient fragmentation or wear of the stone or stone fragment.
- the medical device of the present invention may be used on its own to fragment, wear and extract stones or may be used following a separate fragmentation procedure to extract the fragmented stones produced by the previous procedure.
- the suction monitoring means may comprise flow sensors to directly monitor the flow rate of the fluids passing through the hollow probe.
- the suction means may comprise pressure sensors to monitor the flow rate with reference to the pressure of the fluids flowing through the hollow probe.
- the suction monitoring means may comprise both flow sensors and pressure sensors.
- the medical device additionally comprises temperature monitoring means and the ultrasound generation means is adjusted in response to a temperature detected by the temperature monitoring means.
- the ultrasound generation means may be adjusted or deactivated in response.
- the ultrasound generation means may be activated and/or deactivated manually or automatically in response to a signal generated by the temperature monitoring means.
- the signal may be an audible and/or visible alarm to enable a user of the device to manually respond to the temperature detected or the signal may be an electronic signal enabling computer control means to automatically respond to the temperature detected.
- both manual and automatic control of the ultrasound generation means in response to a temperature detected by the temperature monitoring means may be enabled.
- the frequency and strength of the ultrasound may be varied manually or automatically in response to the temperature detected by the temperature monitoring means. This ensures that the probe cannot reach temperatures at which damage may be caused to a patient's body tissue.
- the temperature monitoring means may comprise at least one temperature sensor.
- a temperature sensor may be coupled to the hollow probe to directly measure the temperature of the hollow probe.
- a temperature sensor may also be located within the device so that, in use, it measures the temperature of the fluid flowing through the device.
- the temperature monitoring means may comprise means to calculate the temperature of the probe using the amount of energy used by the device.
- the hollow probe is reusable; however, the hollow probe may also be disposable.
- the hollow probe will commonly have an external diameter of from 3 mm to 6 mm and/or an internal diameter of from 2 mm to 5 mm. Additionally, the hollow probe may range in length from 200 mm to 400 mm.
- the hollow probe may comprise at least one of titanium, stainless steel and another biocompatible metal.
- Suitable ultrasound generation means will commonly comprise a piezoelectric motor.
- the ultrasound generation means may be adjusted to alter the strength and/or the frequency of the ultrasound, this can increase the efficiency of the ultrasound.
- probes to enter a patient's body. Often the probes need to be fixed to the medical device such that they are able to rotate, vibrate or move in some way. Additionally, such probes often need to be disconnected from and reconnected to the device. This may be because the physician wishes to exchange one size of probe for another, because the probes used are reusable and a recently used probe needs to be cleaned and sterilised before re-use or because the probes used are disposable and so the medical device requires a new probe to be fitted for use in each procedure.
- Prior art fixation systems commonly comprise screw threads, clips or grips.
- U.S. Pat. No. 6,695,782 discloses multiple embodiments of fixation systems for a device that removes occlusions in blood vessels using an ultrasonic probe, in which the probe is reversibly attached to a handpiece using complementary screw threads on the body of the device and the base of the probe or using a collet-type grip.
- Some medical devices comprise bodies with end caps, the exchange of a reversibly attached probe with such medical devices has previously required the complete disconnection of the end cap from the body of the medical device, removal of the old probe by withdrawing its whole length through the hole at the head of the end cap, insertion of a new probe by passing its whole length through the same hole in the end cap, and reconnection of the end cap to the body of the device.
- This is a time consuming and awkward procedure, and enables contamination of a new probe by an old probe due to material being transferred onto the area around the hole in the end cap as the old probe is withdrawn through the hole and then the new probe contacting this material as it is passed through the same hole. Contamination can be particularly problematic if the probe is hollow, as the contamination may lead to blockage of the probe.
- an improved means of fixing a probe to the body of a medical device comprises at least one chuck for reversibly fixing the probe to the body of the device.
- the at least one chuck may be used to fix any kind of probe to the body of a lithotripsy device, but is particularly suited to fixing the probes of ultrasonic lithotripsy devices, suction lithotripsy devices and mechanical shock-wave fragmentation lithotripsy devices.
- the easy exchange of a probe is particularly helpful for medical devices using hollow probes (e.g. lithotripsy suction probes) as these probes can become blocked (e.g. by a urinary tract stone or stone fragment).
- Hollow probes tend to be used to suck a mixture of liquid(s) and solid(s) out of the body of a patient. Since the liquid(s) could damage parts of the device, it is preferable that when a hollow probe is fixed to the body of the device a water-tight seal is created.
- the at least one chuck may be located within an end cap located on the distal end of the body of the device. Exchange of the probe with such a fixation system is simpler than with prior art systems.
- the process for exchanging the probe only requires the connection between the end cap and the body of the device to be loosened, which loosens the grip of the at least one chuck on the old probe, the old probe can then be removed by disconnecting the base of the probe from the at least one chuck within the cap, a new probe can be inserted by introducing the base of the new probe into the hole at the head of the cap to enable the base of the probe to connect with the at least one chuck within the cap, and tightening the connection between the cap and the body of the device also tightens the grip of the at least one chuck on the new probe.
- the loosening and tightening of the end cap can act directly on the at least one chuck or the loosening and tightening of the end cap can act on a mechanism within the end cap which in turn acts on the at least one chuck.
- the probe may pass through the body of the device from the distal end of the body of the device to the proximal end of the body of the device and the at least one chuck is located at the proximal end of the body of the device.
- the at least one chuck at the proximal end of the body of the device may also be located within an end cap.
- the process for exchanging a probe using a proximal end cap requires the connection between the end cap and the body of the device to be loosened, removal of the old probe by disconnecting the base of the probe from the at least one chuck within the cap, inserting a new probe by introducing the base of the new probe through the body of the device to enable the base of the probe to connect with the at least one chuck within the cap, and tightening the connection between the cap and the body of the device.
- the at least one chuck may be located within an end cap at either the distal end or the proximal end of the device, or in a third embodiment at least one chuck is located within an end cap at the distal end of the device and at least one chuck is located within an end cap at the proximal end of the device.
- the probe passes through a distal end cap and through the body of the device to the proximal end of the body of the device.
- Both the distal end cap and the proximal end cap may be wholly detachable from the body of the device to assist in sterilisation.
- the distal end cap and the proximal end cap may be attached to the body of the device such that they may only be loosened during exchange of the probes, but not removed.
- a first ring may be used to help locate the at least one chuck accurately on the body of the device. Such a ring may be located within an end cap between the at least one chuck and the distal or proximal end of the body of the device.
- the first ring may comprise metal.
- a second ring may be used to help create a seal between an end cap and the body of the device when an end cap is connected to the body.
- Such a ring may be located between an end cap and the body of the device.
- the second ring may comprise rubber.
- the at least one chuck should be made of a hard and flexible material, and should be suited to efficient ultrasound transmission. Commonly the at least one chuck will comprise a metal such as titanium or stainless steel, however, reinforced plastics have also been shown to be suited to ultrasound transmission. Additionally, since the body of the device may come into contact with bodily fluids during use, parts of the body of the device will commonly require sterilisation following each procedure the device is used in. Sterilisation usually involves the parts requiring sterilisation being placed in an autoclave at an elevated temperature (e.g. 134° C.) for a minimum period of time (e.g. 18 mins). Since the at least one chuck may need to be sterilised the use of materials suited to repetitive sterilisation is preferred.
- an elevated temperature e.g. 134° C.
- Many medical devices comprise handpieces that a practitioner holds when the device is in use. These handpieces need to be ergonomically designed, easy to manipulate and lightweight. The requirement that handpieces be lightweight is especially important for handpieces that are used in time consuming procedures when the practitioner needs to be able to use the handpiece comfortably and confidently whilst bearing the weight of the handpiece throughout the procedure. In such time consuming procedures, it has been found to be desirable that the weight of the handpiece is minimised.
- mains electricity could be used, however, connection to a supply of mains electricity requires the use of power cables that may trail across the floor of the operating theatre creating a hazard. Additionally, mains electricity supplies tend to supply power at a voltage of 100 V or more, and accidental contact with such high voltages can be harmful.
- any portable power supply should be able to produce power over a sufficiently long period of time that the procedure the practitioner is using the device in can be completed.
- Portable power supplies such as batteries, tend to be heavy and generally the longer the device is needed for and the more power that is needed the heavier the required power supply will be. Therefore handpieces requiring a substantial amount of power during operation necessitate a heavy power supply.
- the handpiece of a medical device be lightweight, therefore incorporating a heavy power supply within a handpiece is not desirable.
- the handpiece may come into contact with bodily fluids during use and therefore will commonly require sterilisation following each procedure it is used in.
- Sterilisation usually involves the handpiece being placed in an autoclave at an elevated temperature (e.g. 134° C.) for a minimum period of time (e.g. 18 mins). Providing a power supply capable of reuse following sterilisation is difficult.
- a convenient means to provide power to a medical device comprises a handpiece that requires electrical power during operation may comprise an integration unit, the handpiece being connected to the integration unit and the integration unit comprising a docking station for at least one battery and means to monitor the operation of the device.
- Isolating the medical device from the mains electricity supply is advantageous as it prevents accidental exposure of users of the device and patients to high voltages. Additionally, mains electricity is earthed whereas the at least one battery used in the present invention is not. This provides an additional safety feature.
- the at least one battery may be disposable or may be rechargeable. If a rechargeable battery is used, a recharger will be required.
- the recharger may be connectable to the mains power supply to readily enable the battery to be recharged. Generally, the recharger would not be used in a sterile area.
- a range of rechargeable batteries are suitable for use in the present invention, including nickel metal hydride (NiMH), nickel cadmium (NiCd), lithium ion (Li-ion) and lithium polymer (Li-polymer) batteries.
- NiMH nickel metal hydride
- NiCd nickel cadmium
- Li-ion lithium ion
- Li-polymer lithium polymer
- the docking station enables the power supplied from the at least one battery to be supplied to the handpiece.
- the integration unit includes means of connecting the supply of a resource required by the handpiece to the handpiece. This encompasses the supply of power, but may also encompass the supply of suction, fluid(s) and/or pharmaceutical products.
- the integration unit includes means to monitor the operation of the device.
- the means to monitor the operation of the device may include one or more of means to monitor the electrical power used by the device, means to monitor the supply of fluid(s) to the device, means to monitor the evacuation of fluid(s) from the device, means to monitor the supply of pharmaceutical products to the device, ultrasound monitoring means and suction flow monitoring means.
- Suction may be supplied to the medical device via the integration unit or independently of the integration unit, e.g. from a vacuum system within the hospital in which the device is being used or by a separate suction pump.
- the integration unit may include control means to control the operation of the handpiece, or the control means may be integrated into the handpiece itself, or control means may be integrated into both the integration unit and the handpiece.
- the integration unit may comprise fixing means to ensure that a practitioner can manipulate the medical device freely during use without any movement of the integration unit interfering with the procedure.
- the fixing means may be suitable to enable the integration unit to be fixed to an operating table.
- the fixing means may comprise a clamp and or suction pads.
- Use of the medical system of the present invention may include use of an endoscope, optionally an endoscope comprising irrigation means.
- the irrigation means may simplify use of the endoscope and may reduce the temperature of the probe.
- Saline is commonly used as the irrigation fluid.
- FIG. 1 is a schematic diagram of one embodiment of a medical device according to the present invention.
- FIG. 1 shows a portable lithotripsy device 10 comprising a handpiece 12 and an integration unit 14 .
- a probe 16 is fixed to the handpiece 12 using a chuck 18 mounted within the end cap 20 of the handpiece. In use, the probe 16 is fed through an endoscope 22 into a patient.
- the handpiece 12 comprises a piezo stack 24 for generating ultrasonic vibrations that are transmitted by the probe 16 to a urinary tract stone within the patient.
- Suction may be supplied to the probe 16 using suction means (not shown) that is connected to the handpiece 12 via the integration unit 14 or directly to the handpiece 12 .
- Power is supplied to the handpiece 12 by the battery 26 connected to the docking station 28 of the integration unit 14 .
- the battery 26 may be disconnected from the docking station 28 for recharging using a recharger 30 , which, in use, is connected to the mains supply of electricity.
- a system according to the present invention was tested in an endoscope with the piezoelectric motor set to maximum power (60 W) and the irrigation system set to a minimum flow rate. After 5 minutes of continuous operation the temperature of the handpiece and the tip of the probe was measured and found to be 45° C. and 25° C. respectively.
Abstract
Description
- This invention relates to a medical device for the safe and efficient removal of urinary tract stones.
- Urinary tract stones are solid concretions formed from minerals present in urine. Small stones can pass from the body in urine without notice, however, larger stones can become lodged in the ureter, kidneys or bladder causing discomfort and/or pain.
- There are many different techniques used to treat urinary tract stones ranging from non-invasive techniques, such as extracorporeal shock wave lithotripsy (ESWL), to invasive techniques such as surgery, basket extraction, laser fragmentation, mechanical shock-wave fragmentation or ultrasonic fragmentation. If fragmentation is used, the fragments of the stone may be allowed to pass from the body in the urine alternatively the fragments may be extracted using basket extraction or suction.
- Medical devices comprising ultrasonic probes (e.g. probes transmitting energy in the range of from 20 kHz to 200 kHz) have a variety of applications, including the fragmentation and/or wear of urinary tract stones or the removal of occlusions in blood vessels. Ultrasonic fragmentation commonly uses a piezoelectric motor to generate ultrasound from a high frequency electrical voltage. The piezoelectric motor is usually located in a handpiece and the vibrations resulting from the ultrasound are usually transmitted to a probe that is inserted via an endoscope into the body. This allows the tip of the probe to come into direct contact with a urinary stone, such that the vibrations cause the stone to fragment or wear.
- Often a urinary stone will fragment or wear after only a few seconds of vibrations being applied, however, longer periods of application of vibrations may be required to fragment or wear some stones and/or repetitive application of vibrations may be necessary to result in sufficiently small fragments. The longer the period of time the probe is used for the more the vibrations will contribute to an increase in the temperature of the local environment of the probe. Since the probe is in an inserted location within a patient, overheating is a serious problem. If the probe is allowed to reach excessively high temperatures the patient's body tissue can be damaged.
- The present invention offers an improved device for the removal of urinary tract stones.
- In accordance with a first aspect of the present invention, there is provided a medical device comprising a body and a hollow probe, ultrasound generation means and suction monitoring means, wherein, in use, suction is applied through the hollow probe, and wherein the ultrasound generation means is adjusted in response to a suction flow rate detected by the suction monitoring means. Suction may be supplied from a vacuum system within the hospital in which the device is being used, or may be supplied by a separate suction pump.
- If the suction flow rate reduces the ultrasound generation means may be activated in response and if, following activation of the ultrasound generation means, the suction flow rate increases the ultrasound generation means may be deactivated in response. The ultrasound generation means may be activated and/or deactivated manually or automatically in response to a signal generated by the suction monitoring means. The signal may be an audible and/or visible alarm to enable a user of the device to manually respond to the suction flow rate detected or the signal may be an electronic signal enabling computer control means to automatically respond to the suction flow rate detected. Of course both manual and automatic control of the ultrasound generation means in response to a suction flow rate detected by the suction monitoring means may be enabled. Additionally the frequency and strength of the ultrasound may be varied manually or automatically in response to the extent of the reduction or increase in the suction flow rate.
- The suction flow rate can be reduced by a fragment of a urinary tract stone becoming lodged within the hollow probe or by a stone blocking the tip of the hollow probe because it is too large to enter into the probe. Activating the ultrasound generation means when a blockage is detected allows the hollow probe to be used to fragment or wear the stones and thereby clear the blockage. Continuing to apply suction during a blockage ensures that the stone is held in contact with the probe surface and therefore ensures that the ultrasound vibrations are transmitted efficiently to the stone or stone fragment, resulting in the efficient fragmentation or wear of the stone or stone fragment.
- The medical device of the present invention may be used on its own to fragment, wear and extract stones or may be used following a separate fragmentation procedure to extract the fragmented stones produced by the previous procedure.
- The suction monitoring means may comprise flow sensors to directly monitor the flow rate of the fluids passing through the hollow probe. The suction means may comprise pressure sensors to monitor the flow rate with reference to the pressure of the fluids flowing through the hollow probe. Alternatively, the suction monitoring means may comprise both flow sensors and pressure sensors.
- In one embodiment of the present invention, the medical device additionally comprises temperature monitoring means and the ultrasound generation means is adjusted in response to a temperature detected by the temperature monitoring means.
- If the temperature monitoring means detects that the hollow probe has reached a high temperature, such as a temperature in excess of 40° C.., the ultrasound generation means may be adjusted or deactivated in response. The ultrasound generation means may be activated and/or deactivated manually or automatically in response to a signal generated by the temperature monitoring means. The signal may be an audible and/or visible alarm to enable a user of the device to manually respond to the temperature detected or the signal may be an electronic signal enabling computer control means to automatically respond to the temperature detected. Of course both manual and automatic control of the ultrasound generation means in response to a temperature detected by the temperature monitoring means may be enabled. Additionally the frequency and strength of the ultrasound may be varied manually or automatically in response to the temperature detected by the temperature monitoring means. This ensures that the probe cannot reach temperatures at which damage may be caused to a patient's body tissue.
- The temperature monitoring means may comprise at least one temperature sensor. A temperature sensor may be coupled to the hollow probe to directly measure the temperature of the hollow probe. A temperature sensor may also be located within the device so that, in use, it measures the temperature of the fluid flowing through the device. Alternatively, or in addition to the temperature sensors, the temperature monitoring means may comprise means to calculate the temperature of the probe using the amount of energy used by the device.
- In one embodiment, the hollow probe is reusable; however, the hollow probe may also be disposable.
- The hollow probe will commonly have an external diameter of from 3 mm to 6 mm and/or an internal diameter of from 2 mm to 5 mm. Additionally, the hollow probe may range in length from 200 mm to 400 mm. The hollow probe may comprise at least one of titanium, stainless steel and another biocompatible metal.
- Suitable ultrasound generation means will commonly comprise a piezoelectric motor.
- In one embodiment the ultrasound generation means may be adjusted to alter the strength and/or the frequency of the ultrasound, this can increase the efficiency of the ultrasound.
- Many medical devices use probes to enter a patient's body. Often the probes need to be fixed to the medical device such that they are able to rotate, vibrate or move in some way. Additionally, such probes often need to be disconnected from and reconnected to the device. This may be because the physician wishes to exchange one size of probe for another, because the probes used are reusable and a recently used probe needs to be cleaned and sterilised before re-use or because the probes used are disposable and so the medical device requires a new probe to be fitted for use in each procedure.
- Prior art fixation systems commonly comprise screw threads, clips or grips. For example U.S. Pat. No. 6,695,782 discloses multiple embodiments of fixation systems for a device that removes occlusions in blood vessels using an ultrasonic probe, in which the probe is reversibly attached to a handpiece using complementary screw threads on the body of the device and the base of the probe or using a collet-type grip.
- Some medical devices comprise bodies with end caps, the exchange of a reversibly attached probe with such medical devices has previously required the complete disconnection of the end cap from the body of the medical device, removal of the old probe by withdrawing its whole length through the hole at the head of the end cap, insertion of a new probe by passing its whole length through the same hole in the end cap, and reconnection of the end cap to the body of the device. This is a time consuming and awkward procedure, and enables contamination of a new probe by an old probe due to material being transferred onto the area around the hole in the end cap as the old probe is withdrawn through the hole and then the new probe contacting this material as it is passed through the same hole. Contamination can be particularly problematic if the probe is hollow, as the contamination may lead to blockage of the probe.
- In one embodiment of the present invention, an improved means of fixing a probe to the body of a medical device comprises at least one chuck for reversibly fixing the probe to the body of the device. The at least one chuck may be used to fix any kind of probe to the body of a lithotripsy device, but is particularly suited to fixing the probes of ultrasonic lithotripsy devices, suction lithotripsy devices and mechanical shock-wave fragmentation lithotripsy devices.
- The easy exchange of a probe, is particularly helpful for medical devices using hollow probes (e.g. lithotripsy suction probes) as these probes can become blocked (e.g. by a urinary tract stone or stone fragment). Hollow probes tend to be used to suck a mixture of liquid(s) and solid(s) out of the body of a patient. Since the liquid(s) could damage parts of the device, it is preferable that when a hollow probe is fixed to the body of the device a water-tight seal is created.
- The at least one chuck may be located within an end cap located on the distal end of the body of the device. Exchange of the probe with such a fixation system is simpler than with prior art systems. The process for exchanging the probe only requires the connection between the end cap and the body of the device to be loosened, which loosens the grip of the at least one chuck on the old probe, the old probe can then be removed by disconnecting the base of the probe from the at least one chuck within the cap, a new probe can be inserted by introducing the base of the new probe into the hole at the head of the cap to enable the base of the probe to connect with the at least one chuck within the cap, and tightening the connection between the cap and the body of the device also tightens the grip of the at least one chuck on the new probe. Depending on the shape and configuration of the end cap, the loosening and tightening of the end cap can act directly on the at least one chuck or the loosening and tightening of the end cap can act on a mechanism within the end cap which in turn acts on the at least one chuck.
- Alternatively, the probe may pass through the body of the device from the distal end of the body of the device to the proximal end of the body of the device and the at least one chuck is located at the proximal end of the body of the device. The at least one chuck at the proximal end of the body of the device may also be located within an end cap. The process for exchanging a probe using a proximal end cap requires the connection between the end cap and the body of the device to be loosened, removal of the old probe by disconnecting the base of the probe from the at least one chuck within the cap, inserting a new probe by introducing the base of the new probe through the body of the device to enable the base of the probe to connect with the at least one chuck within the cap, and tightening the connection between the cap and the body of the device.
- The at least one chuck may be located within an end cap at either the distal end or the proximal end of the device, or in a third embodiment at least one chuck is located within an end cap at the distal end of the device and at least one chuck is located within an end cap at the proximal end of the device. In this embodiment the probe passes through a distal end cap and through the body of the device to the proximal end of the body of the device.
- Both the distal end cap and the proximal end cap may be wholly detachable from the body of the device to assist in sterilisation. However, in alternative embodiments the distal end cap and the proximal end cap may be attached to the body of the device such that they may only be loosened during exchange of the probes, but not removed.
- A first ring may be used to help locate the at least one chuck accurately on the body of the device. Such a ring may be located within an end cap between the at least one chuck and the distal or proximal end of the body of the device. The first ring may comprise metal.
- A second ring may be used to help create a seal between an end cap and the body of the device when an end cap is connected to the body. Such a ring may be located between an end cap and the body of the device. The second ring may comprise rubber.
- The at least one chuck should be made of a hard and flexible material, and should be suited to efficient ultrasound transmission. Commonly the at least one chuck will comprise a metal such as titanium or stainless steel, however, reinforced plastics have also been shown to be suited to ultrasound transmission. Additionally, since the body of the device may come into contact with bodily fluids during use, parts of the body of the device will commonly require sterilisation following each procedure the device is used in. Sterilisation usually involves the parts requiring sterilisation being placed in an autoclave at an elevated temperature (e.g. 134° C.) for a minimum period of time (e.g. 18 mins). Since the at least one chuck may need to be sterilised the use of materials suited to repetitive sterilisation is preferred.
- Many medical devices comprise handpieces that a practitioner holds when the device is in use. These handpieces need to be ergonomically designed, easy to manipulate and lightweight. The requirement that handpieces be lightweight is especially important for handpieces that are used in time consuming procedures when the practitioner needs to be able to use the handpiece comfortably and confidently whilst bearing the weight of the handpiece throughout the procedure. In such time consuming procedures, it has been found to be desirable that the weight of the handpiece is minimised.
- If a medical device comprising a handpiece requires electrical power during operation, a power supply will be required. Mains electricity could be used, however, connection to a supply of mains electricity requires the use of power cables that may trail across the floor of the operating theatre creating a hazard. Additionally, mains electricity supplies tend to supply power at a voltage of 100 V or more, and accidental contact with such high voltages can be harmful.
- It could be desirable to have a portable medical device in which the power supply is incorporated within the handpiece itself, however, depending on the power required this could be problematic. Additionally, any portable power supply should be able to produce power over a sufficiently long period of time that the procedure the practitioner is using the device in can be completed. Portable power supplies, such as batteries, tend to be heavy and generally the longer the device is needed for and the more power that is needed the heavier the required power supply will be. Therefore handpieces requiring a substantial amount of power during operation necessitate a heavy power supply. As described previously, it is desirable that the handpiece of a medical device be lightweight, therefore incorporating a heavy power supply within a handpiece is not desirable. Additionally, the handpiece may come into contact with bodily fluids during use and therefore will commonly require sterilisation following each procedure it is used in. Sterilisation usually involves the handpiece being placed in an autoclave at an elevated temperature (e.g. 134° C.) for a minimum period of time (e.g. 18 mins). Providing a power supply capable of reuse following sterilisation is difficult.
- Equally isolating a power supply within the handpiece such that it is not exposed to bodily fluids is also difficult.
- In one embodiment of the present invention, a convenient means to provide power to a medical device comprises a handpiece that requires electrical power during operation may comprise an integration unit, the handpiece being connected to the integration unit and the integration unit comprising a docking station for at least one battery and means to monitor the operation of the device.
- Isolating the medical device from the mains electricity supply is advantageous as it prevents accidental exposure of users of the device and patients to high voltages. Additionally, mains electricity is earthed whereas the at least one battery used in the present invention is not. This provides an additional safety feature.
- The at least one battery may be disposable or may be rechargeable. If a rechargeable battery is used, a recharger will be required. The recharger may be connectable to the mains power supply to readily enable the battery to be recharged. Generally, the recharger would not be used in a sterile area.
- A range of rechargeable batteries are suitable for use in the present invention, including nickel metal hydride (NiMH), nickel cadmium (NiCd), lithium ion (Li-ion) and lithium polymer (Li-polymer) batteries.
- The docking station enables the power supplied from the at least one battery to be supplied to the handpiece. The integration unit includes means of connecting the supply of a resource required by the handpiece to the handpiece. This encompasses the supply of power, but may also encompass the supply of suction, fluid(s) and/or pharmaceutical products.
- Additionally, the integration unit includes means to monitor the operation of the device. The means to monitor the operation of the device may include one or more of means to monitor the electrical power used by the device, means to monitor the supply of fluid(s) to the device, means to monitor the evacuation of fluid(s) from the device, means to monitor the supply of pharmaceutical products to the device, ultrasound monitoring means and suction flow monitoring means.
- Suction may be supplied to the medical device via the integration unit or independently of the integration unit, e.g. from a vacuum system within the hospital in which the device is being used or by a separate suction pump.
- The integration unit may include control means to control the operation of the handpiece, or the control means may be integrated into the handpiece itself, or control means may be integrated into both the integration unit and the handpiece.
- Conveniently, the integration unit may comprise fixing means to ensure that a practitioner can manipulate the medical device freely during use without any movement of the integration unit interfering with the procedure. The fixing means may be suitable to enable the integration unit to be fixed to an operating table. The fixing means may comprise a clamp and or suction pads.
- In accordance with a second aspect of the present invention, use of the medical device of the present invention is provided.
- Use of the medical system of the present invention may include use of an endoscope, optionally an endoscope comprising irrigation means. The irrigation means may simplify use of the endoscope and may reduce the temperature of the probe. Saline is commonly used as the irrigation fluid.
- In order that the invention may be more fully understood, the following FIGURE and Example are provided by way of illustration only.
-
FIG. 1 is a schematic diagram of one embodiment of a medical device according to the present invention. -
FIG. 1 shows a portable lithotripsy device 10 comprising ahandpiece 12 and anintegration unit 14. Aprobe 16 is fixed to thehandpiece 12 using achuck 18 mounted within theend cap 20 of the handpiece. In use, theprobe 16 is fed through anendoscope 22 into a patient. Thehandpiece 12 comprises apiezo stack 24 for generating ultrasonic vibrations that are transmitted by theprobe 16 to a urinary tract stone within the patient. Suction may be supplied to theprobe 16 using suction means (not shown) that is connected to thehandpiece 12 via theintegration unit 14 or directly to thehandpiece 12. Power is supplied to thehandpiece 12 by thebattery 26 connected to thedocking station 28 of theintegration unit 14. Thebattery 26 may be disconnected from thedocking station 28 for recharging using arecharger 30, which, in use, is connected to the mains supply of electricity. - A system according to the present invention was tested in an endoscope with the piezoelectric motor set to maximum power (60 W) and the irrigation system set to a minimum flow rate. After 5 minutes of continuous operation the temperature of the handpiece and the tip of the probe was measured and found to be 45° C. and 25° C. respectively.
Claims (30)
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0901614.8 | 2009-01-03 | ||
GB0901612A GB0901612D0 (en) | 2009-01-30 | 2009-01-30 | Power supply |
GB09091612.2 | 2009-01-30 | ||
GB0901614A GB0901614D0 (en) | 2009-01-30 | 2009-01-30 | Fixation system |
GB0901610A GB0901610D0 (en) | 2009-01-30 | 2009-01-30 | Medical device |
GB0901610.6 | 2009-01-30 | ||
PCT/IB2010/000308 WO2010086741A1 (en) | 2009-01-30 | 2010-02-01 | Medical device |
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US20120065553A1 true US20120065553A1 (en) | 2012-03-15 |
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US13/147,187 Abandoned US20120065553A1 (en) | 2009-01-03 | 2010-02-01 | Medical device |
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US (1) | US20120065553A1 (en) |
EP (1) | EP2393437B1 (en) |
WO (1) | WO2010086741A1 (en) |
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US9549850B2 (en) | 2013-04-26 | 2017-01-24 | Novartis Ag | Partial venting system for occlusion surge mitigation |
US9549851B2 (en) | 2015-01-28 | 2017-01-24 | Novartis Ag | Surgical hand piece with integrated pressure sensor |
US9561321B2 (en) | 2011-12-08 | 2017-02-07 | Alcon Research, Ltd. | Selectively moveable valve elements for aspiration and irrigation circuits |
US20180193046A1 (en) * | 2017-01-06 | 2018-07-12 | Translational Technologies, LLC | Extracorporeal shockwave lithotripsy (eswl) system and method using in-situ sensing of system and device data and therapeutic/system/device level control |
WO2022067092A1 (en) * | 2020-09-25 | 2022-03-31 | Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America | Anti-clogging during calculi evacuation |
US11547479B2 (en) * | 2016-08-25 | 2023-01-10 | Gyrus Acmi Inc. | Automatic irrigation-coordinated lithotripsy |
Families Citing this family (1)
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US8337416B2 (en) | 2010-07-23 | 2012-12-25 | Cook Medical Technologies Llc | Biopsy device |
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Publication number | Priority date | Publication date | Assignee | Title |
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US9561321B2 (en) | 2011-12-08 | 2017-02-07 | Alcon Research, Ltd. | Selectively moveable valve elements for aspiration and irrigation circuits |
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WO2022067092A1 (en) * | 2020-09-25 | 2022-03-31 | Gyrus Acmi, Inc. D/B/A Olympus Surgical Technologies America | Anti-clogging during calculi evacuation |
Also Published As
Publication number | Publication date |
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EP2393437B1 (en) | 2017-04-19 |
EP2393437A1 (en) | 2011-12-14 |
WO2010086741A1 (en) | 2010-08-05 |
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